NZJ — Respirator, N95, For Use By The General Public In Public Health Medical Emergencies Class II
FDA product code NZJ covers "Respirator, N95, For Use By The General Public In Public Health Medical Emergencies", a Class II medical device regulated under 21 CFR 880.6260. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NZJ
- Device Class
- Class II
- Regulation Number
- 880.6260
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.